MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MP RECONSTRUCTION PROTHESIS CEMENTLESS; MP RECONSTRUCTION STEM CEMENTLESS

Model Number	172-918/16
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An mp modular stem system, originally implanted on (b)(6) 2021, was revised because of infection.The implants were removed and replaced with an antibiotic spacer.

• Brand Name: MP RECONSTRUCTION PROTHESIS CEMENTLESS
• Common Device Name: MP RECONSTRUCTION STEM CEMENTLESS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16770520
• Report Number: 3006721341-2023-00009
• Device Sequence Number: 3251381
• Product Code: LWJ
• UDI-Device Identifier: 04026575320615
• UDI-Public: (01)04026575320615(17)230331(10)1807141
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2023
• Report Date (Section F): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 172-918/16
• Device Catalogue Number: 172-918/16
• Device Lot Number: 1807141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2023
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 52 YR
• Patient Sex: Male